Prevention of Very Preterm Delivery by Testing for and Treatment of Bacterial Vaginosis (PREMEVA)

January 22, 2014 updated by: University Hospital, Lille

Randomized Multicenter Trial for the Prevention of Preterm Delivery by Testing for and Treatment of Bacterial Vaginosis in the First Trimester of Pregnancy

Background. Anomalies of the vaginal flora (bacterial vaginosis, BV) are associated with an increased risk of late abortions and preterm birth. Studies of antibiotic treatment of BV to reduce the risk of prematurity have not found a statistically significant diminution of risk (<= 32 wks: OR=0.49 [0.05-5.1], < 37 wks: OR=0.83 [0.59-1.17]).A partial explanation of these findings is that some of these treatment were administered vaginally, most often during the second or third trimester

Aim: To reduce the frequency of late abortions and very preterm birth by prescribing clindamycin vs placebo to patients diagnosed with BV before 13 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients diagnosed with BV before 13 weeks will be divided into two groups. They will be defined as at low risk when they have no history of spontaneous preterm delivery or late abortion. Women with such histories will be defined as at high risk.

Low risk patients will be asked to participate in a trial with 3 equal parallel groups, comparing two regimes of clindamycin (one or three 4-day treatments of clindamycin 300 mgx2/d) and placebo.

High-risk patients will be asked to participate in a trial with 2 parallel groups to assess the usefulness of repeating antibiotic treatment monthly by comparing the administration of one 4-day treatment of clindamycin (300 mgx2/d) to three 4-day treatments, one month apart.

Study Type

Interventional

Enrollment (Actual)

3105

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59 000
        • Hopital Jeanne de Flandre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Nugent score >= 7
  • pregnant women < 15 weeks (strictly)
  • signed informed consent
  • >=18 old
  • speaking and understanding French language

Exclusion Criteria:

  • metrorrhagias during 7 days before
  • birth anticipated in an other area
  • clindamycin allergy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Clindamycin Cure 1
Arm 1
Drug: Clindamycin
300 mg capsules (per os) Intervention= 2 capsules/d during 4 days: three times a month apart
Other Names:
  • non applicable
Drug: Clindamycin
300 mg capsules (per os) Intervention= 2 capsules/d during 4 days: one time and then, after one month placebo capsules 2 capsules/d during 4 days: two times a month apart
Other Names:
  • non applicable
Active Comparator: Clindamycin Cure 2
Arm 2
Drug: Clindamycin
300 mg capsules (per os) Intervention= 2 capsules/d during 4 days: three times a month apart
Other Names:
  • non applicable
Drug: Clindamycin
300 mg capsules (per os) Intervention= 2 capsules/d during 4 days: one time and then, after one month placebo capsules 2 capsules/d during 4 days: two times a month apart
Other Names:
  • non applicable
Placebo Comparator: Placebo
Arm placebo
Drug: Placebo
Double blinded capsules(per os) Intervention= 2 capsules/d during 4 days: three times a month apart
Other Names:
  • non applicable

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Premature delivery (16 to 32 weeks of gestation)
Time Frame: At delivery
At delivery

Secondary Outcome Measures

Outcome Measure
Time Frame
Preterm labor, PPROM, Spontaneous preterm labor, PROM, Abruptio placentae, Chorioamnionitis, Fever > 38°C during labor, Post partum fever (> 38°), Post-partum wound infections, Perinatal death, NICU transfer, Bacterial neonatal colonisation.
Time Frame: At delivery
At delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Collaborators

Pfizer

Investigators

  • Principal Investigator: Damien SUBTIL, MD PhD, University Hospital, Lille (France)
  • Study Chair: Gilles Brabant, MD, Groupe Hospitalier de l' Institut Catholique, Lille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

March 21, 2008

First Submitted That Met QC Criteria

March 24, 2008

First Posted (Estimate)

March 25, 2008

Study Record Updates

Last Update Posted (Estimate)

January 23, 2014

Last Update Submitted That Met QC Criteria

January 22, 2014

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 060216
  • PHRC 2004/1918 (Other Identifier: DHOS)
  • PHRC 2008/1929 (Other Identifier: DHOS)
  • 2004/0428 (Other Identifier: sponsor)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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